ES2284904T3 - PROCEDURE FOR WELDING WITH CONTINUITY OF MEDICAL CAPSULES MATTER FOR INHALATION AND WELDING APPLIANCE. - Google Patents

Abstract

Procedure for welding by means of the partial element material itself of a plastic capsule for inhalers, containing inhalation medications, the capsule consisting of at least one lid and a body and optionally of other partial elements, which can be fit together in a telescopic way, setting in the overlapping zone or in the overlapping areas of the partial elements in each case a weld seam, where - the capsule cap and the capsule body are held by a support capsule holder composed of two parts that can be moved synchronously with each other, - where one part of the capsule holder surrounds by means of its shape attached to the capsule lid and the other part of the capsule holder similarly surrounds the capsule body, so that the overlap zone between the two parts is not covered, in which the welding seam must be configured, while the s other areas of the cap and the capsule body are covered by the capsule holder; and - where the capsule closed and protected in this way is placed in front of a jet or beam of energy composed of high temperature gas or a laser beam, - the jet or beam of energy being conducted in a relative motion with respect to the capsule at least once in a complete turn around the vertical axis of the area of the capsule elements that overlap each other and are not protected by the capsule holder, or - the capsule is driven into the jet or energy beam by means of the two parts that move synchronously from the capsule holder, without torsional tension or without shear stress, so that the capsule material melts in this area, but is not destroyed, and the overlapping zone is sealed hermetically by means of a seam with union by means of the capsule material itself.

Description

Continuous welding procedure of matter of medical capsules for inhalation and apparatus of welding.

The present invention relates to a new procedure for welding union of plastic capsules for inhalers, as well as to a device that is adapted especially to perform the procedure proposed in the invention. Capsules manufactured by means of the procedure proposed in the invention are disposable capsules for single use and preferably contain a single dose of a formulation pharmaceutical, applicable by inhalation in the form of a powder or a liquid, and are suitable for their shape and function for use in powder inhalers or liquid sprayers for Aerosol production Aerosols produced in this way they can be, for example, inhaled, so that the formulation Pharmaceutical is applied by pulmonary route.

State of the art

Capsules with pharmaceutical preparations are used in multiple ways in therapy and diagnosis of diseases. The capsules can be administered orally or are used in certain medicinal devices, such as inhalers powder. As a rule, the capsules consist of two parts: a capsule body (body) and a capsule lid (lid), which they fit together telescopically. But, they are also known capsules composed of several parts. The capsules are generally made of jelly, especially hard jelly. For some special applications, the capsules sometimes consist also of synthetic materials soluble in water and easily digestible for people, to release in certain compartments of the gastrointestinal tract the active substance, in oral administration case. Below are indicated Examples for various materials for capsules.

EP 0 460 921 describes capsules of chitosan and starch, cereal powder, oligosaccharides, methacrylic acid methacrylate, acid ethyl acrylate methacrylic, acetate or succinate or phthalate hydroxypropylmethyl cellulose.

The material of the capsules is characterized because its content is released only when it reaches the intestine thick.

GB 938 828 proposes capsules for Radioactive substances in therapeutic or diagnostic use.  The capsules consist of water soluble gelatin, methylcellulose, polyvinyl alcohol or non-toxic thermoplastics soluble in Water.

EP 0 312 760 describes a procedure for sealing hard gelatin or starch capsules  with a certain sealing agent. Tailoring of capsules can be displaced from the central plane of the longitudinal axis of the capsule.

Document DE 3 430 764 proposes another procedure to close hard gelatin capsules. In this procedure, the capsules are first filled and then the two halves of the capsule. Then, lifting the capsule lid respect to the body of the capsule, a contact zone is left free in the capsule body, for which the capsule should not be opened. In a next step the contact area becomes "sticky", to then reinsert the cover of the capsule again in its original position, causing it to put in contact with the contact area. This procedure requires high precision in its realization, especially because you have to prevent the capsule from becoming deformed by replacing the lid of the capsule on the capsule body, which has become sticky by heating and therefore is now prone to suffer a deformation. On page 32 of that request it is said that for fastening and driving the capsule parts it They need tools, which should not have any type of tolerances or game.

US 4 991 377 proposes another procedure for heat welding of keratin capsules or jelly. In the proposed procedure the closed capsule, which It consists of two parts joined together in a telescopic way, it is undergoing hot air treatment at the point of your sewing. During the procedure, the lower part of the capsule It is supported on a support. The patent document does not provides no indication as to how it should be be able to avoid deformation of the softened capsules by thermal radiation or on how to avoid the heating or carbonization of other areas of the capsule outside from the welding zone. The way in which the materials contained in the capsule are influenced negatively in its quality because of the heat produced in the heat welding.

WO 00/07572 proposes capsules for inhalers of the kind indicated in the invention, which They consist of non-digestible plastic material. The capsules there described are closed analogously to gelatin capsules lasts usual in the market, that is to say that the capsule lid is fits telescopically over the capsule body. In its case, the seam that is necessarily formed between the lid and the Capsule body can be heat welded, glued or covered with a ring seal, to reduce the vapor permeability of Water. Alternatively, the entire lid can be coated with a continuous protection film or the recess in the area of The seam is closed with a filling material. In that document no details are given on the procedure for closing the lid, especially about no welding procedure.

For welding union of materials various kinds of plastic are known in the state of the art of thermal welding. Among them are welding by ultrasonic, hot plate welding and tools to high temperature, hot gas welding, welding by Rotation, high frequency voltage welding or welding inductively.

On the contrary there are no known procedures of this class to close plastic capsules for inhalers of medicinal use, which are subject to certain framework conditions As for its use.

It has now been proven that these procedures welding can not be transferred without further heat welding of the capsule halves described in WO 00/07572.

Among the framework conditions mentioned above, that oppose a simple handover of the procedure known for the state of the art to inhalation capsules, is found, by example, that the capsules are filled with a formulation pharmaceutical, whose pharmaceutical quality should not be harmed during welding.

Another framework condition is represented by measurements and the wall thickness of the capsules to be welded, especially for the thin walls of a capsule of this class. This condition is necessary, since the capsules must be able to be used in an inhaler of the usual type in the market, in analogous to the hard gelatin capsules used up to now. The capsules should be able to be opened in an easy way. Yes Conventional procedures are applied to a capsule of this class, quickly produced, for example, holes in the capsule due to combustion during welding, especially in areas of the capsule left outside the field that has to be welded. This field, in which the sewing point must be set, is naturally found in an area, where the walls overlap of the two parts that must be joined together. Next to them there are zones, in which there is no overlap of this class. In these areas can easily damage the capsule because of welding operation In addition, there is also the risk that in the case of too thick walls of the capsule, the seam of welding is not continuous at the seam point.

Description of the invention

With the present invention, airtight plastic capsules must be created for inhalation apparatus for medicinal use, which contain a pharmaceutical formulation. These capsules preferably contain a single dose of the formulation. In the context of the present invention, these capsules are called individual dose capsules.
dual.

A preferred inhaler for the purpose proposed here has been described, for example, in WO 94/28958 (HandiHaler®). Of the document EP-A-0 360 765 is known a procedure for welding by means of the material itself a capsule containing medication, consisting of the body of the capsule and capsule cap, in which the capsule body is held by a capsule holder without covering the area of overlapping the capsule cap and capsule body, and using a jet or beam of hot gas energy in a relative motion with respect to the capsule a sewing point is formed in the area of overlapping

Therefore, a mission of the invention it consists of creating a welding procedure and a device specially adapted to it, in which the areas of a capsule plastic, which should not be welded together, do not heat up up to the melting temperature of the plastic.

Another mission is to create a procedure welding for plastic capsules, in which they are fixedly joined each other the various parts of a plastic capsule of this class for inhalers.

Another mission is to unite the various parts of a plastic capsule, so that it is no longer can be separated without damaging the capsule. This allows the user check that the capsule has not already been opened previously.

Another mission is to create a procedure welding for plastic capsules, in which it is not produced no damage to the capsule due to overpressure exerted on the capsule in the welding joint operation or said Overpressure is reduced to a minimum.

Another mission is to create a procedure welding for plastic capsules, in which during the process does not jeopardize the pharmaceutical quality of the medicinal formulation contained in the capsule, which according to the The present invention is a formulation for inhalation.

Another mission of the invention is to unite by welding the sewing point of class inhalation capsules described above on an industrial scale under conditions of "proper manufacturing practice" GMP (= Good Manufacturing Practice)

The present invention solves the missions described above by a method according to claim 1 and a device according to claim 25.

Therefore, it is guaranteed that the welding exclusively from the area to be joined by welding in an inhalation capsule by means of an energy jet in form of a high temperature gas jet or a laser beam. From this way, preferably only heating of the capsule material at the point of sewing.

The capsules that must be welded together consist of preferably hydrophobic plastic materials, not water soluble, which does not essentially influence the quality pharmaceutical of the substances contained, but that improve the possibilities of using full capsules in terms of their function, the duration of its use and / or the region climatological and are advantageous at different stages from the manufacturing until use.

The capsule consists of at least two parts, a capsule body (body) and at least one capsule cap (cover), which can be joined together so that a closed and firm hollow space of a defined volume, which contains The pharmaceutical formulation. The dimensions of the capsule are calculated so that it can be placed in dust inhalers usual, equipped with capsules, such as those described in patent documents DE 33 45 722 (from Inhalator Ingelheim M), EP 0 591 136 (from Inhalator Ingelheim) or in the document of German patent application published DE 43 18 455 ("HandiHaler®"). Especially preferred is the size of capsule 3.

In one embodiment, the plastic of the capsule is not digestible for people, so in case of oral ingestion the active substance is not released. This has the advantage that, in case of accidentally swallowing the capsule, no No major damage to health can occur. This has application especially for young children or older people.

Preferably, plastics are used which can be transformed by injection molding technique  or by blowing and / or plastics for whose transformation into the top of the capsule or capsule body no agent is needed demoulding, which may cause the substances to adhere contained against the capsule wall. This has the advantage of that the inside of the cap or the capsule body does not have to be cleaned to remove the mold release agent, for example to comply with official regulations (for example, according to the Code German of Medicines DAB = Deutsches Arzneibuch), which regulates the use of mold release agents for packaging media primary. Thermoplastics are preferred, which allow a joint by welding through the material of the capsule halves between yes.

Preferred materials have the property of that only the minimum possible dust is adhered to them, but preferably no dust.

Among the plastic materials suitable for procedure recommended in the invention is the LD polyethylene (low density = low density), HD polyethylene (high density = high density), polystyrene, acrylonitril-butadien-styrene, polypropylene, methyl polymethacrylate, polyvinyl chloride, polyoxymethylene, polycarbonate, polyester or polyethylene terephthalate.

In preferred embodiments, the material plastic is polyethylene, especially polyethylene with a density between 900 and 1,000 kg / m 3, but preferably 900 kg / m 3 (high density polyethylene).

In a preferred embodiment, the plastic does not have an outstanding adhesion characteristic for chemical-pharmaceutical substances, especially for particles with breathable size, so that in case of use of the capsule in one of the inhalers described above, The entire contents of the capsule can be released. This has the advantage that this makes it possible to carry out one more dose exact, especially the thin part of breathable size.

In another embodiment, the capsule consists of a plastic material with a Shore D hardness between 65 and 73. A plastic with this hardness does not break into pieces when it is drilled or cut, but at the same time it has enough stiffness so that the hole made in this way does not close on its own. The advantage  of a material of this class is that during the opening, the punching or cutting the capsule in the powder inhaler no jump capsule particles, which could then be aspirated by the user during inhalation.

In one embodiment, the capsule of plastic has such great stability that it resists a force up to 15 N along its longitudinal axis or its axis cross. The advantage of this is that the capsule is better adapted to the efforts, which act on it during the manufacturing, filling, packaging, transportation, etc.

In another embodiment, the material of the capsule has a permeation coefficient for water vapor of less than 10-13 kg / (m s Pa), but preferably less than 1.3 x 10-14 kg / (m s Pa). Preferably the coefficient is between 10-15 and 5x10-16 kg / (m s Pa), but especially preferred between 5 x 10-16 and 2 x 10-16 kg / (m s Pa). The advantage of this property is that the content of the capsule is better protected against water in geographic regions With a high humidity of the air.

The capsule can be used in all kinds of powder inhalers, in which the preparation to be inhaled is introduced by means of a capsule.

In a preferred embodiment, the lid and The capsule body is cylindrical in shape and are similar to each other, consisting of a closed envelope itself with a closed side and an open side in each of the parts. The shape and size of the cap and the capsule body are calculated so that the body can be introduced in a way telescopic with its open end at the open end of the lid, so that the lid is fixedly attached to the body.

In a preferred embodiment, the lid and the body is shaped like a cylinder with a round section and with the convex underside, almost closed in hemispherical form, and both consist of high density polyethylene, with a density between 950 and 1,000 kg / m 3.

In a special embodiment, the lid and The capsule body is provided with closure devices, which are advantageous for the provisional and / or definitive closure of the capsule. In an embodiment of this kind, in the envelope inside the lid are made elevations in the form of points and recesses with form of somewhat larger points, which are arranged so that, when the capsule is closed, the elevations fit into the recesses. Alternatively, the elevations may be configured in the outer body wrap and recesses on the inner wrap of the lid. Provisions are preferred, in which the elevations or recesses are located respectively in shape ring or spiral around the envelope. Instead of the realization in the form of points of elevations and recesses, these can be made in the form of a continuous ring around the lid wrap or capsule body. This last form of interlocking is preferred. In a form of embodiment, in the inner wrap of the lid and in the wrap one or more elevations outside the body are configured ring-shaped perimetrales, so that in the closed state of the capsule, an elevation of the lid is found respectively next to an elevation of the body.

In the embodiments with those mentioned recesses and / or ring-shaped elevations, these can be continuous or interrupted. In another embodiment, in the external sides of the body are set elevations near the open end and holes near the cover are configured open end, so that body elevations fit together in the holes of the lid in the closed state of the capsule. The elevations can be made so that the lid can be open at all times without damaging the capsule, but also so that the capsule can no longer be opened without destroying it, once It has been closed.

One or more capsules are preferred interlocking mechanisms of this class (for example, two slots perimeter).

Especially preferred are capsules with at minus two interlocking possibilities of this class, which set with different strength to the two parts of the capsule. In one of these parts, a first interlocking possibility may be configured near the openings of the lid and the body of the capsule, and a second interlocking possibility may be shifted slightly towards the closed end of the parts of the capsule. The first interlocking possibility then performs the fixation of the two parts of the capsule with less force than the second.

This variant has the advantage that the cover of the capsule and the capsule body can be joined together provisionally before filling, first by means of First interlocking mechanism. Then they separate again two parts of the capsule to fill the capsule. After filling the capsule, the two parts of the capsule, until the second set of interlocks holds stably the capsule parts.

In another embodiment, on the side outside the body is formed a flange, which extends in perpendicular to the axis of union between the capsule and the body, around the body The flange serves as a stop for the capsule, when it is fitted on the body, to prevent the lid penetrate deep into the body. The area between the open end of the body and flange corresponds to the area of the body, on which The lid can be moved. The flange is located in the body so that the lid can be inserted enough depth in the body, to make a firm closure between the Cap and body. That is, the flange is located, by example, not directly on the open side of the body. The side of flange, which is oriented towards the free end of the body, is located as a vertical edge on the outer wall of the body, of so that the lid, when closing, cannot be moved surpassing said flange. The flange side, facing the closed end of the body, can be configured in the form of a almost rectangular edge or it can be flattened towards the end closed body. The configuration of an almost rectangular edge it can be advantageous in case of a loose adjustment of the capsule in a capsule holder, while the variant with flat flange It is advantageous in the case of a fixed setting. The flange can be continuous or interrupted

In a preferred embodiment, the flange is flattened continuously towards the closed end of the body and is located vertically on the capsule body with its side facing the open end of the body. The height of song formed in this way is calculated here so that the edge does not protrude outside the capsule lid when the capsule is closed, so that the transition between the layer and the Capsule body is performed without staggering.

Alternatively to this, instead of the flange, the diameter of the capsule body may be reduced suddenly at one point, so that the diameter oriented towards the opening is smaller (or larger) than the diameter oriented towards the closed end of the body. The lid and the body they can then be configured so that the capsule lacks of step at the sewing point in its closed state.

In another alternative, the shape of the wall of the lid in the opening area is configured exactly  inverse to the shape of the wall of the capsule opening. That is, the wall of the lid widens in the area of the opening, forming an inner edge. Also in this form of embodiment the outer wrap is preferably flat. In this embodiment, the cap fits over the capsule until the edge of the lid and the edge of the capsule are touched.

In another preferred embodiment, the flange is located on the inner side of the capsule body. The edge of the flange, on which the capsule lid rests when the capsule is closed, is then oriented towards the outer side of the capsule body. In such a case, the capsule cap does not fit over the capsule body, but instead fits inside the capsule body. For this, the cover and the body can be configured so that the capsule has no step at the seam point in its closed state. Within the framework of the present invention, both possibilities of fitting the capsule cap onto the capsule body are considered equivalent, that is, if one of the two variants is described, the same also applies to the other.
variant.

In another embodiment, the song of the capsule body is configured with a perimeter development U-shaped, in which the song of the opening of the capsule lid.

In another embodiment, both openings they have a U-shaped development of this class.

Also in another embodiment, the song of the openings of the lid and body is widened and set without stepping towards the opening.

The thickness of the walls of the lid and body It may vary to the full extent. Thus, the wall thickness in the rounded areas of the lid or body or in the area of the body in the one that is configured the flange, is as a rule greater than in areas, where the walls extend in a straight line. In one embodiment, the walls of the lid and the body they are between 0.1 mm and 0.5 mm thick; the capsule has preferably an average wall thickness between 0.1 mm and 0.4 mm, but especially preferably between 0.2 mm and 0.4 mm.

The body of the capsule has in the area of its opening, especially at its edge, a thickness of between 0.15 mm and 0.35 mm but preferably between 0.225 and 0.275 mm, and in shape Especially preferred 0.25 mm.

The capsule lid has in the area of your opening, especially at its edge, a thickness of between 0.25 mm and 0.45 mm, but preferably between 0.325 mm and 0.375 mm, and in shape Especially preferred 0.35 mm.

The capsule length is between 8 mm and 30 mm, but preferably between 13 mm and 17 mm and in shape Especially preferred between 15.5 mm and 16 mm. The diameter of the capsule is between 4 mm and 7 mm, but preferably between 5.3 mm and 6.3 mm and especially preferably between 5.75 mm and 5.95 mm

A preferred capsule has a length of 15.9 mm, a diameter of the capsule body of 5.57 mm and a diameter of the capsule cap of 5.83 mm. The preferred wall thickness of the capsule body is 0.25 mm and that of the capsule lid It is 0.35mm.

In a possible embodiment, on the side outward buttons of the capsule are configured, and in another embodiment three or more ribs are configured, which extend parallel to the longitudinal axis. The advantage of these devices is that the capsule can be used from a capsule holder, such as those used by example in the aforementioned powder inhalers and can be removed so that it is not damaged or opens. The nerves or the outgoing buttons can be distributed all over the side outside of the capsule or they can cover only part of the same. Alternatively they can be configured only on the lid or well only in the area of the body, which can be seen from the outside When the capsule is closed. The nerves extend in parallel to the longitudinal axis of the capsule and make the capsule is fixed perpendicularly to said capsule holder support. In the case of a circular shaped section of the capsule, the nerves are preferably arranged so that the section transverse of the capsule does not have rotation symmetry around of the central axis. In an embodiment of this class, the nerves can only be configured in the area of the body, which It is visible when the capsule is closed. A form of realization of this class prevents the capsule from being locked in a capsule holder.

In another embodiment without flange but with nerves in the body part, which is visible when closed the lid, the nerves are configured so that the ends of the nerves oriented towards the open end of the body fulfill the mission of the flange, specifically serve as a stop for the lid by assembling the lid and body together.

In another embodiment, the cover wraps and The capsule body forms a hollow cylinder with section round, oval, triangular, quadrangular, hexagonal, octagonal or polygonal, the respective upper side being open and the side bottom closed. The closed bottom side can be flat or convex. Angular embodiments have the advantage, by example, that they can be supported by saving more space than round shapes

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In one embodiment, the elongation of the capsule (distance from the closed end of the body to the closed end of the lid, in relation to the diameter being the closed capsule) is greater than 1; in another embodiment, the elongation is equal to 1, and again in another embodiment, the elongation is less than 1. The latter has the advantage that the body has a larger opening for filling.

In one of the embodiments with a elongation equal to 1, the lid and body are made of so that the closed lid is shaped like a ball, which can be advantageous for automatic charging of a powder inhaler with the capsule from a supply tank.

In the description you can see that the capsule made according to the invention is especially suitable for contain any type of pharmaceutical powder formulation and suitable for inhalation. In a special form of use, the capsule contains as active substance chromoglycine acid, reproterol, beclomethasone, terbutaline, salbutamol, salmeterol, ketotifen, orciprenaline, fluticasone, insulin, ipratropium, tiotropium, dexamethasone, bambuterol, budesonide, fenoterol, Clenbuterol, prednisolone, prednisone, prednilidene, methylprednisolone, formoterol, nedocromil, their salts or mixtures pharmacologically compatible, or another cortisone preparation or Atropine derivative, suitable for inhalation purposes.

In a preferred form of use, the Capsule contains ipratropium bromide or tiotropium bromide.

Welded closed capsules can also accommodate liquids, in addition to dust loads, and are suitable then also for the new liquid inhalers.

For closing by means of the material of the at least two partial elements of the capsule, which can be fit telescopically into each other, it is especially suitable a procedure, in which a very limited jet of energy locally, high temperature gas or a laser beam, is driven in a relative motion at least once fully around the vertical axis of the area of the capsule elements  that should overlap, so that the capsule material in this area is softened by fusion, but it is not destroyed and form in this area a sewing point with union by means of material.

The rotation movement can be performed in so that the capsule rotates around its axis, located in perpendicular to the weld seam plane, rotate in the jet of energy or that the jet of energy is driven around of the capsule.

The seam of the capsule is then joined by welding in one turn or in several turns.

Welding procedures are preferred, in which the weld seam with union by means of the material is set in several turns, since this way you can get better control of the welding operation. By example, in this way it can be prevented that on the wall of the capsule holes form due to combustion.

Preferably, in the procedure recommended in the invention high temperature gas is used and laser rays. In case of use of laser beams, the energy thermal required for welding bonding is induced by means of absorption in the capsule material.

The welding joint operation itself said can take place either directly at the point of sewing the two parts of the capsule, or the part in the that both halves of the capsule overlap each other.

The weld seam formed in this way is configured as one or several closed lines along the capsule perimeter parallel to the two planes and between them, that form the openings of the capsule and the body. Fit preferred, the seam is hermetically sealed in all its contour by means of the method recommended in the invention.

In addition to the closed lines themselves as welding seam, spiral lines are also possible. The configuration of welding seams, however, is not limited to straight-line shapes, it can also be made in the form of zigzag or meanders or in any other way spreading around the capsule wrap. Sewing welding can also be performed as welding union by points.

Preferably the seam of welding at a point, in which the capsule body and the cap of the capsule just begin to overlap each other. As may be the procedure used, you can also perform several welding seams, which may be located, by example, in parallel with each other.

In the case of capsules formed by several parts, welding seams are needed at all points of union, to achieve the desired clamping effect and sealing. In capsules composed of two or more parts, several welding seams next to each other increase the sealing security.

Depending on the body size of the capsule and capsule cap, you can choose the position of welding seams centered on the axis longitudinal. However, an asymmetric position is preferable, to ensure the greatest possible distance to the load of product contained in the capsule.

This can also be achieved, for example, making the capsule body longer than the lid of the capsule, or vice versa. In relation to this, it is understood by length the distance between the opening of any one of the two halves of the capsule and the closed side opposite. The seam is preferably in the upper third of the closed capsule This means that the body part of the capsule from the closed bottom to the point of configuration of the flange described above, which marks the point to which it fits the open end of the capsule lid to the body of the capsule through the opening of the latter, is approximately 2/3 of the total length of the capsule closed.

A capsule of this class has the advantage of what filling height of the formulation inside the capsule can be below the sewing point, so that it is reduced considerably the risk of diminishing the quality of the formulation because of the welding joint operation.

The filling height of the capsule can be adapted according to the welding temperature and the temperature sensitivity of the pharmaceutical formulation.

Therefore, the present invention allows also the production of a plastic capsule of this class with Asymmetrical position of welding seam. The others characteristics of the capsule have already been described in detail at beginning.

The use of a measuring device lets you know the welding temperature and the behavior of creep of the capsule material during the operation of welding and therefore allows selective control.

The welding procedure is performed preferably by re-coupling with the data coming of the measuring device, to achieve high quality constantly the same as welding seam. In this way you can get a uniform contribution of energy to the point of welding.

The re-coupling compensates the oscillations, for example, of the thickness of the material, as well as of the influences of the environment, correcting the regulation of the speed of rotation of the relative rotation or the energy fed. In this regard, it is preferable to fuse a part as small as possible of the capsule and measure the temperature or radiation exactly at this point. By means of the rotation the sewing of
welding.

In the process recommended in the invention, the fed energy and the relative rotation speed are preferably synchronized with each other, so that the capsule material just begins to soften. Repeating this process one or several times, a weld seam with joint is obtained by means of
material.

Below are the temperatures, which they are necessary for the softening of the materials Preferred for the capsule. The examples have no character Limiting on materials.

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According to the melting temperature, the jet of energy, its distance to the surface of the capsule and its average duration of permanence on the capsule surface they graduate so that the capsule material is melted, without to produce a hole in the capsule wall.

The rotation speed of the power jet around the capsule or the capsule in the jet of energy can be between 0.01 revolutions per second and a maximum of 40 revolutions per second. In the case of lightning welding laser, the rotation speed can preferably be between 0.1 and 15 revolutions per second; in the case of gas welding at high temperature, the rotation speed can be preferably between 0.2 and 2 revolutions per second.

This results in a rotation speed of the preferred capsule with a length of 15.9 mm and a diameter of the capsule cap of 5.83 mm and a body diameter of the 5.57 mm capsule, approximately 0.18 mm per second and 732 mm per second. In the case of the welding process by laser beam, the rotation speed is preferably between 1.8 mm per second and 366 mm per second, and in the case of high temperature gas welding the rotation speed is between 3.7 mm per second and 37 mm per second.

The capsule / jet speed of energy can be up to 40, but preferably up to 20 for a welding joint operation. In the case of the procedure Welding by laser beam, the number of revolutions is preferably between 2 and 3 and in the case of gas welding High temperature is between 5 and 8.

In the welding procedure proposed in the present invention, the capsules and the energy source are approximate each other preferably with a feed rate determined. Preferably, feed rates of between 0.1 cm per second and 10 cm per second, but in a way especially preferred between 1 cm per second and 5 cm per second.

Through the procedure recommended in the invention the capsules can be welded with a cycle time of preferably less than 10 seconds.

Procedures are more preferred, in which the capsule is welded in 5 seconds, but even more preferred are procedures in which welding is done in 1 second.

This gives another advantage of procedure proposed in the present invention: by means of short welding times, the formation of bubbles due to the heating of the gas contained in the capsule.

Capsules manufactured according to the procedure recommended in the invention preferably have an axis of symmetry C_ {n} (n = degree of symmetry) and a plane of symmetry, which in the ideal case it is perpendicular to the axis of symmetry. The latter criterion is limited to cylindrical capsules with seam of welding located in a centered position with respect to the axis of symmetry. Especially preferred are capsules. rotary-symmetric

For this, it is not essential that the perimeter of the capsules have a circular shape. The perimeter can also be polygonal or elliptical.

The preferred exterior configuration of the Capsule has no steps. Capsules are especially preferred made of plastic according to the patent application document Published DE 198 35 346-A1.

In the case of laser welding and embodiments of the capsules with polygonal section or elliptical, welding seams are subjected to radiation without focus at an average working distance with a medium dose, or either preferably with an active regulation of the rays, causing the focus to shift synchronously with respect to the rotation according to the geometry of the capsule or very well especially preferred with intensity regulation, which compensates for blurring by increasing power.

Before the welding operation itself said preparatory measures must be taken. These measures are due to the consideration of welding requirements in terms of energy source used, the construction of the capsules in their geometric aspect and in terms of the choice of material, as well as to the choice of additives, for example dyes, which are due add to one or several parts of the capsule. The latter are preferably used in the case of lightning welding To be.

The advantage of dyes in plastic is that the colors absorb light from the plastic in the plastic laser and thus heat the plastic locally to the point that a weld joint occurs.

For this, the dyes used are adjusted for the frequency of the laser beam light and for the amount of heat is needed.

Dyes are chosen as dyes that do not modify the pharmaceutical quality of the formulation in the capsule. Dyes are preferably used for products food.

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Examples of especially preferred dyes They are:

2

Among these, especially preferred are inorganic pigments

Additives can be applied on the finished parts of the capsule (for example, by means of spraying, pressing, brushing, immersion) and then melted in the welding process or incorporated directly to the capsule material already during the manufacture of the capsules, for example in a basic mixing procedure.

When welding by laser beam, to achieve a complete weld joint of the entire perimeter of the capsule, radiation must be applied throughout the perimeter. Is possible linear optics, which simultaneously performs welding of the full perimeter. A relative movement between the capsule and the ray of light and the consequent conduction of the focus of combustion along the entire perimeter of the capsule. By example, this can be done by rotating the capsule in the laser light beam.

Alternatively, by means of mirrors rotating, you can pass the laser beam around the capsule. For this, relative rotation is especially preferred. between the capsule and the laser beam by means of a support, which allows synchronization between the angle of rotation and the activity of the laser beam.

As a measuring device for control re-coupled the welding element, it is used in welding by laser beam preferably a measuring device of the radiation.

The re-coupling compensates the oscillations, by example of the thickness of the material, the reflectivity, the approach and other environmental influences, correcting the regulation of the speed of rotation or preferably the power of the laser beam. In relation to this, preferably the fusion of a small area of the seam material, measuring the temperature and radiation By means of relative rotation before described from the capsule around the laser beam, then the welding seam.

The power of the laser beam necessary for the welding depends on the optics chosen (focus size), on the forward speed, of the surface characteristics of the material (for example, roughness), of the optical properties of the material (for example, transparency) and the temperature of necessary fusion of the material.

For example, plastic capsules have been welded dyed green with an argon ion laser beam of 5 watts (wavelength on the entire line 514 nm and 488 nm); he approach has been performed with a microscope objective (with magnification 10 times) The same capsules could also be welded with an infrared laser (wavelength of about 900 nm) with a radiation power of approximately 100 watts.

Through the welding procedure by laser beam proposed in the present invention can be configured welding seam both immediately and also only after a second radiation operation or other repeated posterior radiations. In case of repetition, the capsule and the light source preferably rotate with each other so that the area already subjected to radiation once has not cooled yet, when the laser beam comes again. The focus of the laser beam is preferably choose just with such a size, that only produce little heat on the inner side of the capsule wall and also located on the seam of the capsule.

The width of the weld seam can be adjusted by means of a rapid oscillating movement of the point of the focus on directions other than the direction of advance of the welding. Width adjustment is preferred by means of the optical reproduction of laser radiation on a focus point, preferably less than 1 mm. It is especially preferred a focus point diameter of less than 0.5 mm.

In the case of welding with high gas temperature, the total weld joint of the entire perimeter of the capsule requires uniform heating of the capsule throughout its perimeter This can be done by means of several nozzles, for example with a crescent shape or a ring shape, which at at the same time they perform the welding of the complete perimeter. Without however, a relative movement of the capsule and a flat jet, produced by a corresponding nozzle with opening flat rectangular The fusion zone created in this way can be then guided along the perimeter of the capsule until you get full welding. The rotation of the capsule by means of a support, which allows synchronization between the angle of rotation and the high temperature gas inlet.

In case of manufacturing individual parts, it is advantageous to use a nozzle or several nozzles with section little.

In case of serial industrial manufacturing, should use one or two long nozzles with slit, in front of which several capsules are also passed at once, making them spin continuously.

In the case of welding with high gas temperature, nozzles with slit can be advantageously used crescent shaped, if the procedure is performed so that The capsules rotate in the heat jet.

The measures of the nozzles slits are they choose so that a very narrow heat stream is formed in relationship with height. The height of the slit hole is preferably up to 3 mm, but preferably up to 2 mm and especially preferably up to 1 mm. The length of the opening is variable. In the case of welding seams no radial, the length should be limited, the same as the height, at 3 mm, but preferably at 2 mm and in shape Especially preferred at 1 mm. In the case of welding seams that extend radially or spirally around of the capsule, the length of the nozzle slit is secondary importance

The height of the weld seam is determined by the height of the nozzle jet. In the case of a weld seam that extends radially around the capsule, the area of the capsule, in which the welding seam, impersonate the power jet in parallel to the longitudinal side of the nozzle arrangement. The nozzle arrangement length and jet temperature of energy determine, together with the welding zone of the material of the capsule, the duration of permanence of the capsule in the jet of energy This means that the longer the opening of the nozzle and at a higher temperature is the jet of energy, the faster you should turn the capsule in parallel to that address. That is, welding seam around the capsule is set parallel to the length of the arrangement of the nozzle.

In such cases, the length of the nozzle with cleft can be many centimeters or it can even be several meters A nozzle with a gap with such length is especially advantageous, if welding seams must be made consecutively in several capsules as a work chain.

The procedure recommended in the invention is preferably controlled so that the weld seam is not form immediately, but only in the second blow application of gas at high temperature or in repeated subsequent operations of blown with gas. The repetition preferably takes place through  Rotation of the capsule and the high temperature gas nozzle each other, before the point under blown.

The gas temperature, necessary for the union by welding, it depends on the melting fields of the materials Plastics used and their distance to the gas nozzle at high temperature. However, to apply on the seam of welding a high temperature gas stream as narrow possible, the capsule is driven in front of the nozzle at very little distance from it. A distance of 5 mm is preferred.

The width of the high temperature gas stream at the welding point it is between 1 mm and 2 mm.

The capsule holder, necessary for the Performing the method according to the invention consists of two shaped pieces separated from each other, whose interior configuration It has a shell shape. The shell-shaped parts are configured so that one of them serves as accommodation adjusted for the body of the capsule, while in the other one hold the capsule lid, so that when the support, only the area of the support remains uncovered by the support seam to be joined by welding.

The advantage of this measure is that only the area of the capsule to be welded must come into contact with the jet of energy, while the remaining areas of the capsule are protected against the jet or energy beam.

Preferably, from the song that should be configured as sewing of the respective capsule halves are should leave up to 3 mm free, but especially preferred between 0.5 mm and 1 mm.

The external configuration of the support does not offer problems, but should allow the passage of gas output to high temperature. For example, the two parts of the capsule holder They can have a cylindrical shape.

The top and bottom of the capsule holder are coupled together so that the Parts position is maintained even when the union by softening or fusion between the individual pieces, without the capsule being exposed to torsion or tension. This is especially important for the welding operation, if the stability of the capsule shape decreases because of heating of a partial zone.

The purpose of the capsule holders consists in holding the capsule and driving it close to the source of energy to perform the welding joint operation. To the the same time also serves to cool the areas of the capsule walls, which should not be welded and therefore also for the protection of the formulation in the capsule.

To protect the formulation against welding operation conditions, filling height of the capsule is preferably below the seam of welding in the protected area.

The capsule holder can be configured so that it refrigerates the capsule. They are suitable for this, for for example, systems with water cooling or elements of Peltier

The capsule holder can be manufactured of metal, for example aluminum, copper, stainless steel, or of a material high temperature resistant plastic, for example polytetrafluoroethylene (= Teflon®).

Preferably, at least a part of the two halves of the capsule holder is attached to a turning device, so that the capsule can rotate around of the power source. Preferably, the support capsule holder itself revolves around its own axis, which is attached between the top and bottom of the support.

Several capsule holders can be placed for example on a conveyor device, preferably in a row. In this case, each capsule holder is attached to the capsule body on a device transport. Above it a second is located in parallel transport device, on which the support for the caps of the capsules, so that every time there is a capsule with its body in the support provided for it and the cover of the capsule is in the support provided for it. The devices of transport are configured so that the two halves of the capsule holders can be separated from each other after the solder joint, so that the capsules only remain in one of the two halves, preferably in the middle destined to the original capsule body. This can be done, for example, making transport devices tapes continuous conveyors, which are first installed moving away from each other divergently within the same plane of according to the place of the weld joint. Then the Capsules can be removed from the holder.

In another embodiment, the supports may be attached to the transport device by means of an outwardly movable arm telescoping. These arms are displaced outward in the direction of the other arm, when welding the capsule, so that the capsule is protected by the two antipodes of the support in the form described above. After the welding operation, the arms come together again, so that the two halves of the support move, separating each other.

In this way, the capsules can be driven bringing them closer to the source of energy.

The supports are preferably supported by rotating form on themselves on the transport device. As soon as the capsule has been transported inside a stream of energy, the capsule holder rotates like a set on itself and thus causes the capsule to rotate in the power jet, so that the welding seam is formed Around the capsule.

In the case of capsule holders that are supported in a non-rotating way, the power jet can be properly driven around the capsule.

During the welding operation, by means of the heating forms an overpressure in the capsule. This pressure It represents a considerable risk, since, in the case of heating too strong, the formation of bubbles in the heated walls of the capsule. The support capsule holder made according to the invention provides advantageously it also helps with respect to this source of risks.

Additionally, the capsule holder protects also to the parts of the capsule that do not have to be welded each other, as well as the formulation contained in the capsule.

Through the procedure recommended in the invention, capsules for inhalers containing pharmaceutical products, which are completely waterproof, so that the pharmaceutical product cannot leave the capsule without It is destroyed.

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The advantage of capsules manufactured according to the invention is that they have a very small permeability to water vapor, especially in the area of sewing, and therefore can also be used in different regions weather conditions, for example in weather region 3 with a high humidity, without suffering quality Pharmaceutical formulation. These capsules, also in others different stages of the life of the capsule, since its manufacture Until they are used, they have several advantages in relation to ability to use the capsule as a support for preparations Pharmacists, substance management class contained in the capsules, the shelf life of the contained substances and / or the possibility of using the Capsules in certain countries. Another advantage of the materials of the capsules according to the present invention consist, for example, of that have no tendency to bind materials in powder form, so that an exact dosage of the fraction is provided thin breathable

These capsules can also be used in non-medicinal sprays

Description of the drawings

The attached drawings show by way of example different embodiments of the manufactured capsules according to the invention, serving only for illustration, without limiting by that is the scope of the invention.

- Figure 1 shows the simplest and preferred of the capsule made according to the invention, seen in lateral section

- Figures 2a and 2b show each one a different embodiment of the capsule with a flange that It narrows in the body, seen in lateral section.

- Figure 3 shows an embodiment of the capsule with rim in the form of a ridge in the body, seen in lateral section

- Figure 4 shows an embodiment of the capsule with flange that narrows in the body and with ring-shaped recess in the body and lid, seen in cross section.

- Figure 6 shows an embodiment of the capsule with flange that narrows in the body and with recesses or elevations in the form of points on the body and on the lid, in front view.

- Figure 7 shows an embodiment of the capsule with flange that narrows in the body and with elevations in the form of points on the body and holes in the form of points on the cover, in front view.

- Figure 8 shows an embodiment of the capsule with nerves located in the body, in view frontal.

- Figure 9 shows the capsule of Figure 7 in horizontal section.

- Figures 10a, 10b and 10c show ways of realization of the capsule, each with a section different.

- Figures 11a to 11g show different embodiments of capsules 1 with the closing point located in a centered position between the lid and the body, to perform welding seam 13.

- Figures 12a through 12h show capsules with different forms of welding seam (in a straight line, in spiral, meandering, zigzag shaped, welds point bonding, non-continuous welding seams, which extend diagonally in parallel).

- Figure 13 shows a support capsule holder

- Figure 14 shows a capsule holder located in the energy stream of a laser beam.

- Figure 15 shows a capsule holder with a capsule, around which the beam is driven To be.

- Figure 16 shows a capsule holder in the power jet of a high temperature gas nozzle.

- Figure 17 shows a capsule, in which the welding seam is configured between cover 2 and body 3 perpendicular to the longitudinal axis of the capsule.

- Figure 18 shows a capsule, which consists of two covers 2 and one body 3.

An exemplary embodiment with a capsule with Ball shape is not represented in the drawings.

Figure 1 shows the form of simplest embodiment of the capsule 1 made according to the invention, cross-sectional view. Capsule 1 consists of a cover 2 and body 3, which are fitted together in shape telescopic Cap 2 and body 3 have the same configuration, each of them with a convex bottom 4.

In figure 2a it is shown in section transversal an embodiment, in which the body 3 of the capsule 1 is configured a flange 55, which narrows towards the closed end of the body. With the side facing the open end of the body, the flange 5 is almost in perpendicular to the body. The song configured in this way limits the area of the body, on which it can be introduced telescopic cover 2.

Another embodiment is reproduced in the figure 2b. The cross section shows that this form of embodiment differs from the form depicted in figure 2a in that the wall thickness of the cover 2 or of the body 3 is not equal throughout the area, but varies throughout partial areas individual. Additionally, the convex bottom sides 4 of the cover or body each have a shaped entree concave at the point of its vertex.

Figure 3 shows a form of embodiment, in which the flange 5 rests on the body almost at a right angle to both the upper side of the body, and also with respect to its lower side.

The embodiment of Figure 4 represents a more advanced development of the embodiment of Figure 2a, in which the lid 2 or the body 3 is configured a recess 6 or 7 respectively in the form of a ring, to improve the closure of the capsule 1.

Figure 5 shows a front view of the embodiment represented in cross section in the figure 4.

Figure 6 shows another variant of the invention with insulated recesses 8 and 9, in front view.

A variant of the capsule 1, in which in body 3 elevations are made 10 holes are made near the upper end and in the cover 2 11 near the upper end, so that the elevations 10 are they fit into holes 11 when the capsule is closed.

Figure 8 represents an embodiment of capsule 1, seen from the outside, in which in body 3 the nerves are configured 12.

Figure 9 shows the body 3 of the shape of embodiment of figure 7, cross-sectional view. The section indicates that the three nerves 12 are not positioned rotary-symmetric around the central axis of the body.

Figure 10a shows a capsule 1 with section with quadrangular section, while in figure 10 it shows the capsule with triangular section and in figure 10c the capsule with octagonal section.

Various embodiments of capsules 1 are shown in Figures 11a to 11g, in which the closure zone between the lid and the body to form the weld seam 13 is not located in a centered position. Figure 11a shows a closure, in which on the outer side of the body a ridge 5 displaced inwardly is configured and on the inner side of the lid a ridge 5 oriented outwardly is configured. The joint is reinforced by means of an interlocking point, but preferably two interlocking points. Figure 11b shows an embodiment, in which only the body has an inwardly displaced edge 5. The lid and body close together without staggering. Figure 11c shows an embodiment, in which only an inwardly displaced edge 5 is configured on the lid. The body does not have this characteristic. The lid and body close together without staggering. Figure 11d shows an analogous embodiment, in which one or more projections or recesses or cavities adjusted to those are configured in the counter-part are configured in the overlap area between the cover and the body. achieve a better provisional closure before welding. Figure 11e shows an embodiment, in which the closure is carried out so that the body has no closure characteristics, while the lid has at its open end a U-shaped bifurcated flange 21, which can be fitted in the open edge of the body wall. Figures 11f and 11g show embodiments, in which the thickness of the walls of the open ends 22 of the body and of the lid are thickened to achieve a wider contact area in the closing part between the two halves of the
capsule.

Figures 12a through 12i show capsules 1 with different shapes of welding seam 13: in the figures a), c) and d) the shape is shown in a straight line; in figure e) it show spot welding joints; in figure f) it show the zigzag shape; in figures g) and h) are shown discontinuous welding seams, which extend diagonally in parallel; in figures b) and i) the welding seam has spiral shape

Figure 13 shows a capsule holder 14, composed of the support 15 for the capsule body 3 and the support 16 for the cap 2 of the capsule.

Figure 14 shows a capsule holder 14 located in the energy beam 18 of a laser beam 17.

Figure 15 shows a capsule holder 14 with a capsule 1, around which the laser beam is driven 18 by means of two mirrors.

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Figure 16 shows a capsule holder 14 located in the power jet of a gas nozzle 20 at high temperature. The nozzle can be configured here also with wider, so that they can pass in several rows capsules simultaneously in front of the nozzle shaped cleft

Figure 17 shows a capsule, in which the welding seam is configured between capsule 2 and body 3 perpendicular to the longitudinal axis of the capsule.

Figure 18 shows a capsule composed of two caps 2 and a body 3. In this case, the body represents a tube open to both sides, being open side closed respectively by a cover 2.

In all embodiments, the characteristics described with respect to the lid and the body for solder joint of the capsules, may also be located conversely, that is the closing characteristics that found on the lid can be set on the body and when reverse.

Examples

Typical service data for air blowers at high temperature:

Steinel high temperature air blower 1800 W, electronically regulated; special nozzle with opening 1 mm x 7 mm; hot air temperature about 250 ° C in the exit of the nozzle; capsule rotation by means of a motor steps with a speed of less than 3 revolutions per second at a 10mm distance

Service data for the lightning device To be:

The service data is predetermined by the respective laser beam apparatus. 0.75 seconds are achieved by each capsule with a light output of approx. 30 watts

The average length of stay of a point of welding in the case of laser beam welding and with a point of focus of 0.1 mm in diameter is approximately 22 milliseconds, if the capsule performs 2 revolutions in a time of 8 seconds, what which corresponds to a rotation speed of 4.6 mm per second. For this a capsule with a length of 15.9 mm has been used, with a capsule body diameter of 5.57 mm and with a capsule cap diameter 5.83 mm, the thickness being wall of the 0.25 mm capsule body and that of the lid of the 0.35 mm capsule.

In the case of an ion laser beam apparatus of 1.5 watt argon a green capsule is used.

In the case of gas welding union a high temperature, results for the same capsule an average duration of permanence of approximately 0.26 seconds, if a high temperature air jet approximately 1 mm high and 7 mm wide and the capsule is rotated 12 times in the jet of gas in a time of 8 seconds. The speed in the perimeter of The capsule is then approximately 27 mm per second.

Examples of capsules

Length of capsule bodies: 22.2 ± 0.46 mm; 20.22 ± 0.46 mm; 20.98 ± 0.46 mm; 18.4 ± 0.46 mm; 16.61 ± 0.46 mm: 15.27 ± 0.46 mm; 13.59 ± 0.46 mm; 12.19 ± 0.46 mm; 9.3 ± 0.46 mm.

Capsule caps length: 12.95 ± 0.46 mm; 11.74 ± 0.46 mm; 11.99 ± 0.46 mm; 10.72 ± 0.46 mm; 9.78 ± 0.46 mm; 8.94 ± 0.46 mm; 8.08 ± 0.46 mm; 7.21 ± 0.46 mm; 6.2 ± 0.46 mm.

Outside diameter of the bodies of the capsules: 9.55 mm; 8.18 mm; 7.36 mm; 7.34 mm; 6.63 mm; 6.07 mm; 5.57 mm; 5.05 mm; 4.68 mm

Outer diameter of capsule caps: 9.91 mm; 8.53 mm; 7.66 mm; 7.64 mm; 6.91 mm; 6.35 mm; 5.83 mm; 5.32 mm; 4.91 mm

Total length of closed capsules: 26.1 ± 0.3 mm; 23.3 ± 0.3 mm; 24.2 ± 0.3 mm; 21.7 ± 0.3 mm; 19.4 ± 0.3 mm; 18.0 ± 0.3 mm; 15.9 ± 0.3 mm; 14.3 ± 0.3 mm; 11.1 ± 0.3 mm.

Capsule volumes: 1.37 ml; 0.95 ml; 0.78 ml; 0.50 ml; 0.37 ml; 0.30 ml; 0.21 ml; 0.13 ml.

Capsule weight: 163 mg; 118 mg; 110 mg; 96 mg; 76 mg; 61 mg; 48 mg; 38mg; 28 mg

Claims (26)

1. Procedure for welding welding by middle of the partial element material itself of a capsule of plastic for inhalers, which contains medicines for inhalation, the capsule consisting of at least one lid and one body and optionally other partial elements, which can be fit together in a telescopic way, setting in the area of overlapping or overlapping areas of partial elements in each case a welding seam, where

-

the Capsule cap and capsule body are held by a capsule holder consisting of two parts that can be moved in sync with each other,

-

in where a part of the capsule holder surrounds with support by half of its shape to the capsule lid and the other part of the Capsule holder also surrounds the capsule body, of so that the overlap zone between both parties is not covered, in which the welding seam should be set while the other areas of the cap and the capsule body remain covered by the capsule holder; Y

-

in where the capsule closed and protected in this way is placed in front to a jet or beam of energy composed of high temperature gas or of a laser beam,

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being conducted the jet or energy beam in a relative motion respect to the capsule at least once in a full turn around the vertical axis of the area of the capsule elements that overlap each other and are not protected by the support capsule holder, or

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the capsule is conducted in the jet or energy beam by means of the two parts that move synchronously from the support capsule holder, without torsional tension or without tension of shear, so that the capsule material melts into this zone, but it is not destroyed, and the zone of overlap is hermetically sealed by means of a seam with joint of the capsule material itself.

2. Method according to claim 1, characterized in that the capsule is surrounded by the shape of the capsule holder, so that an area with a width of up to 3 mm, preferably between 0.5 and 1 mm, is left free to effect the joint by welding. 3. Method according to claim 1 or 2, characterized in that the material of the capsule holder is preferably aluminum, copper, stainless steel or high temperature resistant plastic, such as polytetrafluoroethylene. Method according to one of the preceding claims, characterized in that the capsule is rotated in the jet or energy beam with the area to be joined by welding, the capsule holder preferably supported so that synchronization between the angle is possible. Turn and power jet. 5. Method according to one of claims 1 to 3, characterized in that the jet or energy beam is conducted around the area to be welded in the capsule. Method according to one of the preceding claims, characterized in that the material of the capsule and the working temperature are chosen as follows: polyethylene (low density): 160ºC-260ºC polyethylene (high density): 260ºC-300ºC polystyrene 170ºC-280ºC acrylonitrile-butadien-styrene: 210ºC-275ºC Polypropylene: 250ºC-270ºC polymethacrylate from methyl: 210ºC-240ºC chloride Polyvinyl: 170 ° C-210 ° C, or polyoxymethylene: 200ºC-210ºC. Method according to one of the preceding claims, characterized in that the wall of the capsule has a thickness of 0.05 mm to 0.5 mm, preferably 0.1 mm to 0.4 mm, in a particularly preferred way of 0 , 2 mm to 0.4 mm. Method according to one of the preceding claims, characterized in that the capsule has a length of 8 mm to 30 mm, preferably from 13 mm to 17 mm and especially preferably from 15.5 mm to 16 mm, and has a diameter of 4 mm to 7 mm, preferably 5.3 mm to 6.3 mm. Method according to one of the preceding claims, characterized in that the number of relative revolutions of the capsule in the jet or energy beam is between 0.01 revolutions per second and a maximum of 40 revolutions per second, preferably a maximum of 20 revolutions. per second. Method according to one of the preceding claims, characterized in that the speed of advancement of the capsule is between 0.1 cm per second and 10 centimeters per second, preferably between 1 cm per second and 5 cm per second. Method according to one of the preceding claims, characterized in that during the welding joint, the vertical axis of the weld seam to be performed is perpendicular to the jet or energy beam, and because the height of filling of the medication in The capsule is below the weld seam to be performed. 12. Method according to one of the preceding claims, characterized in that the welding seam to be performed in the capsule is in the upper third of the capsule. 13. Method according to one of the preceding claims, characterized in that a cooling device is configured in the capsule holder. 14. Method according to one of the preceding claims, characterized in that the cooling device is a device for water cooling or a Peltier element. 15. Method according to one of the preceding claims, characterized in that the jet or energy beam is a focused or non-focused laser beam. 16. Method according to claim 15, characterized in that the capsule is stained with a dye that absorbs the energy of the laser beam, at least in the area of the weld seam to be performed. 17. Method according to claim 15, characterized in that the dye is applied or incorporated into the capsule material. 18. Method according to one of claims 15 to 17, characterized in that a dye is chosen as a food coloring dye, preferably from the group of red Fe 2 O 3, red erythrosine, yellow beta-carotine, FeO (OH) yellow, indigotine blue, green chlorophyllin, beige caramel or white titanium dioxide. 19. Method according to one of claims 15 to 18, characterized in that the laser beam is conducted by means of a mirror around the area of the capsule that is to be welded together. 20. Method according to one of claims 15 to 19, characterized in that a radiation measuring device is available therein, which corrects the regulation of the speed of rotation between the capsule and the jet or energy beam or preferably corrects The power of the laser beam. 21. Method according to one of claims 1 to 14, characterized in that the jet or energy beam is a high temperature gas jet with an extension of up to 3 mm, preferably between 0.5 and 1 mm in the area of the capsule that you want to join by welding. 22. Method according to claim 21, characterized in that the relative movement between the jet or energy beam and the area of the capsule to be joined by fusion is carried out at least twice, before the welding seam is fully configured . 23. Method according to one of the preceding claims, characterized in that the capsule consists only of the capsule body and the capsule lid, but otherwise of no other partial element. 24. Method according to one of claims 1-22, characterized in that the capsule consists of the capsule body and the capsule lid and an internally hollow cylindrical central area, whose two open ends can be telescopically attached to the body of the capsule and to the capsule lid. 25. Device for the realization of a process according to one of claims 1 to 24, composed of a device for the production of a jet or beam of energy in shape of a laser beam or a high temperature gas jet, a capsule holder and a device for approaching the capsule holder to the jet or energy beam. 26. Device according to claim 25, characterized in that the device for approximation of the capsule holder is a continuous moving conveyor belt.